EP0871476B1 - Dried blood factor composition comprising trehalose - Google Patents

Dried blood factor composition comprising trehalose Download PDF

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Publication number
EP0871476B1
EP0871476B1 EP96900633A EP96900633A EP0871476B1 EP 0871476 B1 EP0871476 B1 EP 0871476B1 EP 96900633 A EP96900633 A EP 96900633A EP 96900633 A EP96900633 A EP 96900633A EP 0871476 B1 EP0871476 B1 EP 0871476B1
Authority
EP
European Patent Office
Prior art keywords
trehalose
factor viii
dried
drying
nacl
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP96900633A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0871476A1 (en
Inventor
Bruce Joseph Roser
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Quadrant Drug Delivery Ltd
Original Assignee
Elan Drug Delivery Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Elan Drug Delivery Ltd filed Critical Elan Drug Delivery Ltd
Priority to EP08010169A priority Critical patent/EP1974741A1/en
Priority to EP10008828A priority patent/EP2258402A3/en
Priority to EP03002147A priority patent/EP1308170B1/en
Publication of EP0871476A1 publication Critical patent/EP0871476A1/en
Application granted granted Critical
Publication of EP0871476B1 publication Critical patent/EP0871476B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
EP96900633A 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose Expired - Lifetime EP0871476B1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP08010169A EP1974741A1 (en) 1995-01-19 1996-01-19 Dried blood factor composition stabilised by trehalose
EP10008828A EP2258402A3 (en) 1995-01-19 1996-01-19 Dried composition
EP03002147A EP1308170B1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB9501040.1A GB9501040D0 (en) 1995-01-19 1995-01-19 Dried composition
GB9501040 1995-01-19
PCT/GB1996/000119 WO1996022107A1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP03002147A Division EP1308170B1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose

Publications (2)

Publication Number Publication Date
EP0871476A1 EP0871476A1 (en) 1998-10-21
EP0871476B1 true EP0871476B1 (en) 2003-07-23

Family

ID=10768253

Family Applications (4)

Application Number Title Priority Date Filing Date
EP96900633A Expired - Lifetime EP0871476B1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose
EP03002147A Expired - Lifetime EP1308170B1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose
EP08010169A Withdrawn EP1974741A1 (en) 1995-01-19 1996-01-19 Dried blood factor composition stabilised by trehalose
EP10008828A Withdrawn EP2258402A3 (en) 1995-01-19 1996-01-19 Dried composition

Family Applications After (3)

Application Number Title Priority Date Filing Date
EP03002147A Expired - Lifetime EP1308170B1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose
EP08010169A Withdrawn EP1974741A1 (en) 1995-01-19 1996-01-19 Dried blood factor composition stabilised by trehalose
EP10008828A Withdrawn EP2258402A3 (en) 1995-01-19 1996-01-19 Dried composition

Country Status (15)

Country Link
US (2) US6649386B2 (da)
EP (4) EP0871476B1 (da)
JP (1) JP3898221B2 (da)
KR (1) KR100417593B1 (da)
CN (1) CN1152713C (da)
AT (2) ATE245442T1 (da)
AU (1) AU704317B2 (da)
CA (2) CA2210872C (da)
DE (2) DE69637749D1 (da)
DK (2) DK0871476T3 (da)
ES (2) ES2316658T3 (da)
GB (1) GB9501040D0 (da)
PT (2) PT871476E (da)
SI (1) SI1308170T1 (da)
WO (1) WO1996022107A1 (da)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10238718B2 (en) 2014-08-04 2019-03-26 Csl Limited Factor VIII formulation

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
US7244824B2 (en) * 1995-01-19 2007-07-17 Quadrant Drug Delivery Limited Dried blood factor composition comprising trehalose
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US6964771B1 (en) 1995-06-07 2005-11-15 Elan Drug Delivery Limited Method for stably incorporating substances within dry, foamed glass matrices
US6632648B1 (en) * 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
GB9616536D0 (en) * 1996-08-06 1996-09-25 Quadrant Holdings Cambridge Co-amoxiclav dosage form
AUPO871997A0 (en) * 1997-08-25 1997-09-18 Csl Limited Dried biologically or therapeutically active preparations
PT2130554E (pt) * 1999-02-22 2012-11-19 Univ Connecticut Formulações de factor viii isentas de albumina
CN100436466C (zh) * 2001-08-10 2008-11-26 株式会社林原生物化学研究所 海藻糖或麦芽糖醇和金属离子化合物的缔合物
US8541002B2 (en) 2003-09-12 2013-09-24 Agenus Inc. Vaccine for treatment and prevention of herpes simplex virus infection
ATE489105T1 (de) * 2004-03-19 2010-12-15 Baxter Int Faktor ixa zur behandlung von blutungsstörungen
WO2005116081A2 (en) 2004-05-24 2005-12-08 Genvault Corporation Stable protein storage and stable nucleic acid storage in recoverable form
KR100624013B1 (ko) 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
US8133484B2 (en) 2006-12-15 2012-03-13 Lifebond Ltd Hemostatic materials and dressing
CA2673260A1 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
EP1958618A1 (de) * 2007-02-15 2008-08-20 Octapharma AG Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren
US20100316625A1 (en) * 2007-12-21 2010-12-16 Inspiration Biopharmaceuticals, Inc. Stabilized factor ix formulations containing trehalose
US11197916B2 (en) 2007-12-28 2021-12-14 Takeda Pharmaceutical Company Limited Lyophilized recombinant VWF formulations
NZ586383A (en) * 2007-12-28 2012-11-30 Baxter Int Recombinant vwf formulations
WO2010031007A2 (en) 2008-09-12 2010-03-18 Genvault Corporation Matrices and media for storage and stabilization of biomolecules
EP2601932A1 (en) * 2008-10-21 2013-06-12 Baxter International Inc. Lyophilized recombinant VWF formulations
US20100168018A1 (en) 2008-11-07 2010-07-01 Baxter International Inc. Factor viii formulations
JP5796860B2 (ja) 2009-12-22 2015-10-21 ライフボンド リミテッドＬｉｆｅｂｏｎｄ Ｌｔｄ 架橋マトリックスの特性を調節するための酵素的架橋剤の改変
JP2014521084A (ja) * 2011-07-13 2014-08-25 デナトール アクティエボラグ 液状生体試料の安定化法
CN102416171B (zh) * 2011-12-06 2013-12-25 中国医学科学院输血研究所 高纯度凝血酶原复合物制品干热病毒灭活过程中的保护剂
US9700486B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
EA030733B1 (ru) * 2013-12-19 2018-09-28 Янссен Вэксинс Энд Превеншн Б.В. Жидкая композиция для сохранения виросом и способ сохранения виросом
IL293135A (en) 2015-05-13 2022-07-01 Agenus Inc A preparation containing at least two different complexes of purified stress protein linked to an antigenic peptide
CN107333750A (zh) * 2017-06-11 2017-11-10 成都吱吖科技有限公司 一种长时血液细胞稳定剂
AU2019261451A1 (en) 2018-04-26 2020-12-03 Agenus Inc. Heat shock protein-binding peptide compositions and methods of use thereof
CN114072420A (zh) 2019-07-04 2022-02-18 康诺贝林伦瑙有限公司 用于增加凝血因子viii的体外稳定性的截短的血管性血友病因子(vwf)
CN116322920A (zh) 2020-11-09 2023-06-23 武田药品工业株式会社 使用氧化硅吸附从血浆中纯化fviii
WO2022261716A1 (en) * 2021-06-16 2022-12-22 Exopharm Limited Aqueous formulations for preservation of extracellular vesicles

Citations (3)

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Publication number Priority date Publication date Assignee Title
US4891319A (en) * 1985-07-09 1990-01-02 Quadrant Bioresources Limited Protection of proteins and the like
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
US6171825B1 (en) * 1997-04-18 2001-01-09 Bayer Corporation Preparation of recombinant factor VIII in a protein free medium

Family Cites Families (18)

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US4361509A (en) 1981-12-14 1982-11-30 Scripps Clinic And Research Foundation Ultrapurification of factor VIII using monoclonal antibodies
US4495175A (en) * 1982-08-05 1985-01-22 University Of Rochester Preparation of highly purified human antihemophilic factor
FI86885C (fi) 1984-04-20 1992-10-26 Genentech Inc Foerfarande foer framstaellning av human rekombinantfaktor viii och nukleinsyrasekvenser och vektorer anvaend daertill
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US4758657A (en) * 1985-07-11 1988-07-19 Armour Pharmaceutical Company Method of purifying Factor VIII:C
US4806343A (en) * 1986-03-13 1989-02-21 University Of Southwestern Louisiana Cryogenic protectant for proteins
CA1329760C (en) 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
US4877608A (en) * 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
CA2051092C (en) * 1990-09-12 2002-07-23 Stephen A. Livesey Method and apparatus for cryopreparation, dry stabilization and rehydration of biological suspensions
DE4111393A1 (de) 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
US5288853A (en) 1992-04-30 1994-02-22 Alpha Therapeutic Corporation Factor viii purification process
SE504074C2 (sv) * 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering
AU7254894A (en) 1993-07-23 1995-02-20 Baxter International Inc. Activated human factor viii and method of preparation
US5576291A (en) * 1993-09-13 1996-11-19 Baxter International Inc. Activated factor VIII as a therapeutic agent and method of treating factor VIII deficiency
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
PT2130554E (pt) 1999-02-22 2012-11-19 Univ Connecticut Formulações de factor viii isentas de albumina

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4891319A (en) * 1985-07-09 1990-01-02 Quadrant Bioresources Limited Protection of proteins and the like
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
US6171825B1 (en) * 1997-04-18 2001-01-09 Bayer Corporation Preparation of recombinant factor VIII in a protein free medium

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BOEDEKER B.G.D.: "Production processes of licenced recombinant factor VIII preparations", SEMINARS IN THROMBOSIS AND HEMOSTASIS, vol. 27, no. 4, 2001, pages 385 - 394 *
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Internet citation: Bayer Biological Products: Research & development: Production of Factor VIII: Patient's Safety. As retrieved on the internet by the Applicant (date not indicated). *
Internet citation: Hemophilia A concentrates; http://www.med.unc.edu/thromb/comprehe/fviiicon.htm, as retrieved on 28-3-2002 *
Internet citation; AlphaNine SD / Alphanate / Profilnine SD; http://www.alphather.com/products/ins_alhpa.htm, as retrieved on 19-7-1999 *
Prescribing information of antihemophilic factor (human) MONOCLATE-P: factor VIII:c pasteurized, monoclonal antibody purified; U.S. license No. 1281; Aventis Behringer L.L.C., Kankakee, IL 60901, USA *
Rote Liste: Monographs on "Autoplex", "Beriate", Haemoctin", "Immunate STIM plus" and "Octavi". *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10238718B2 (en) 2014-08-04 2019-03-26 Csl Limited Factor VIII formulation

Also Published As

Publication number Publication date
GB9501040D0 (en) 1995-03-08
DE69637749D1 (de) 2008-12-24
ATE245442T1 (de) 2003-08-15
EP2258402A2 (en) 2010-12-08
US7803911B2 (en) 2010-09-28
JP3898221B2 (ja) 2007-03-28
EP1308170A3 (en) 2004-03-03
EP1308170B1 (en) 2008-11-12
ES2316658T3 (es) 2009-04-16
DE69629209T2 (de) 2004-02-19
CA2210872A1 (en) 1996-07-25
ATE413885T1 (de) 2008-11-15
DE69629209D1 (de) 2003-08-28
EP1308170A2 (en) 2003-05-07
EP0871476A1 (en) 1998-10-21
DK1308170T3 (da) 2008-12-15
ES2202425T3 (es) 2004-04-01
EP1974741A1 (en) 2008-10-01
KR100417593B1 (ko) 2004-04-30
PT1308170E (pt) 2008-12-26
WO1996022107A1 (en) 1996-07-25
JPH11503719A (ja) 1999-03-30
EP2258402A3 (en) 2011-01-05
KR19980701500A (ko) 1998-05-15
SI1308170T1 (sl) 2009-04-30
CA2671383A1 (en) 1996-07-25
PT871476E (pt) 2003-12-31
AU4454096A (en) 1996-08-07
DK0871476T3 (da) 2003-11-10
CA2210872C (en) 2009-09-08
CN1179107A (zh) 1998-04-15
US20090149388A1 (en) 2009-06-11
US20020128207A1 (en) 2002-09-12
AU704317B2 (en) 1999-04-22
CA2671383C (en) 2012-04-24
US6649386B2 (en) 2003-11-18
CN1152713C (zh) 2004-06-09

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